Unmet Needs

V.F.0

Lead Author(s):

Kenneth S. Saag, MD, MSc

While the burden of osteoporosis is growing significantly, the declining pattern of osteoporosis testing and treatment has created considerable unmet need and clear opportunities for new treatments and programs. Even after a fracture, many healthcare providers do not discuss osteoporosis with their patients. Indeed, fractures beget fractures: Fractures at nearly any site are significantly associated with subsequent fractures,1,2 emphasizing the need for new drugs, treatment care approaches, and research funding to test the effectiveness of new therapies and treatment approaches.

Edition:

2014

New Drugs

V.F.1

Lead Author(s):

Kenneth S. Saag, MD, MSc

There are three new drugs being tested as potential osteoporosis treatments.

Abaloparatide

Abaloparatide is an analog of parathyroid hormone-related protein (PTHrP) being developed as a potential anabolic agent for osteoporosis treatment. In a phase 2 study, abaloparatide increased BMD at the lumbar spine, femoral neck, and total hip in a dose-dependent fashion. The abaloparatide-induced BMD increases either trended to or were significantly greater than those seen with teriparatide. Phase 3 studies will evaluate fracture outcome and additional safety with this therapy.

Odanacatib

Odanacatib is a selective inhibitor of cathepsin K, a collagenase produced by osteoclasts and responsible for the degradation of bone mineral and matrix. Women receiving odanacatib for five years gained BMD at the spine and hip, and showed bone biomarker changes somewhat different from those seen with bisphosphonates and typical antiresorptive therapies.1,2 Also in contrast with bisphosphonates, after odanacatib discontinuation there was rapid reversal of treatment effects. Although the safety profile has been mild, cathepsin inhibitors have been associated with a scleroderma-like skin lesion. Other potential safety signals are being further investigated.

Anti-sclerostin antibodies

Sclerostin is produced by osteocytes and inhibits anabolic signaling pathway important for bone formation. Rare natural deficiencies in sclerostin result in sclerosing bone diseases, sclerosteosis, and van Buchem disease, which are radiographically characterized by thickened bones, including all long bones. Monoclonal antibodies to sclerostin are being investigated for both osteoporosis treatment and for fracture healing. Preliminary studies suggest a significant increase in BMD with the anti-sclerostin romosuzumab.3 Phase 3 clinical trials evaluating fracture risk protection are underway.

Edition:

2014

Fracture Liaison Service

V.F.2

Lead Author(s):

Kenneth S. Saag, MD, MSc

Coordination of acute postfracture care with subsequent secondary osteoporosis prevention and treatment is a tenet of good osteoporosis management. Although most people who experience a fracture receive excellent and appropriate acute care management in a hospital or emergency department, most are not subsequently referred to or do not pursue postfracture osteoporosis care with a bone health specialist.

The fracture liaison service (FLS) is a model of care developed in Europe and successfully implemented in a number of US managed health care systems that seeks to facilitate postfracture care coordination. FLS operates under the supervision of bone health specialists and collaborates with primary care, orthopedic, and emergency department health care providers. Care typically is coordinated postfracture through a nurse or other allied health professional. Patients with recent fractures are tracked via a registry, and timelines are established for postfracture assessments and follow-ups. FLS programs recognize that patients who have fractured are at highest risk of future fractures. FLS programs in certain settings have reduced the number of fractures and have achieved cost savings by identifying and appropriately treating postfracture patients.

The efficiency of the FLS approach varies depending on its intensity and potentially the location of its implementation.1,2

Edition:

2014

Research Funding

V.F.3

Lead Author(s):

Kenneth S. Saag, MD, MSc

The National Institutes of Health (NIH) supports both basic and clinical investigation in osteoporosis. Within the NIH, the National Institute of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS); the National Institute on Aging (NIA); the National Institute of Dental and Craniofacial Research (NIDCR); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); and The National Institute of Child Health and Human Development (NICHD) all support osteoporosis-related research. NIAMS[1], the top institute for osteoporosis research, reported $72 million in osteoporosis research funding in fiscal year 2014, with an NIH-wide total of $141 million for osteoporosis-related projects.1 Additional research support is provided by other federal agencies including the Agency for Health Care Research and Quality[2] (AHRQ), the Centers for Disease Control and Prevention[3] (CDC), and the Veterans Administration Research[4] program. The new Patient-Centered Outcomes Research Institute[5] (PCORI) has also supported osteoporosis research. The top private and agency funds for osteoporosis include the American Society of Bone and Mineral Research [6]and the American College of Rheumatology[7]. Although numerous agencies fund osteoporosis research, the dollars available are limited in comparison to other conditions prevalent in older Americans. Additional research funding would assist in identifying treatments, management strategies, and factors that can minimize the burden associated with osteoporosis.